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Continuous and Daily Oral Immunotherapy for Peanut Allergy: Results from a 2-Year Open-Label Follow-On Study

Brian P Vickery1, Andrea Vereda2, Caroline Nilsson3

  • 1Emory University School of Medicine, Atlanta, Ga.

The Journal of Allergy and Clinical Immunology. in Practice
|December 28, 2020
PubMed

Insights

Daily oral immunotherapy with Peanut (Arachis Hypogaea) allergen powder-dnfp (PTAH) demonstrated sustained safety and efficacy in peanut-allergic children and adolescents beyond one year, showing ongoing immunomodulation.

Area of Science:

  • Allergy and Immunology
  • Clinical Trials
  • Food Hypersensitivity

Background:

  • The PALISADE trial established the efficacy of daily oral immunotherapy using Peanut (Arachis Hypogaea) allergen powder-dnfp (PTAH) in children and adolescents with peanut allergy.
  • This established the foundation for further investigation into long-term treatment and alternative dosing strategies.

Purpose of the Study:

  • To evaluate the safety and efficacy of continued oral immunotherapy with PTAH beyond one year in peanut-allergic individuals.
  • To explore alternative dosing regimens for PTAH in both previously treated and treatment-naive participants.

Main Methods:

  • The ARC004 study enrolled participants from the PALISADE trial, including those continuing PTAH treatment and those new to it.
  • Participants received daily or non-daily PTAH dosing, with naive participants undergoing dose escalation.
  • Safety and efficacy were assessed through adverse event monitoring and exit double-blind placebo-controlled food challenges up to 2000 mg peanut protein.

Main Results:

  • 358 participants (ages 4-17) entered the study, with 256 continuing PTAH and 102 being PTAH-naive.
  • Adverse event rates were generally higher in non-daily dosing cohorts compared to daily, with most events being mild or moderate.
  • Daily dosing cohorts showed higher desensitization rates, particularly cohort 3A with the longest daily treatment duration.
  • PTAH continuation demonstrated ongoing immunomodulation, and outcomes in PTAH-naive participants mirrored the original PALISADE trial's active arm.

Conclusions:

  • Continued daily oral immunotherapy with PTAH beyond one year is safe and effective for managing peanut allergy.
  • The treatment supports sustained desensitization and demonstrates ongoing immunomodulatory effects during the second year of therapy.
Abstract

Keywords:
Allergic reactionsDesensitizationDosing regimensOral immunotherapyPeanut allergy

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